MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STONE CONE; DISLODGER, STONE, FLEXIBLE

Model Number	M0063903200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's second address is luquan yi and miao autonomous county.Imdrf impact codes f1001 capture the reportable event of absence of treatment.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone was to be used on a flexible ureteroscopic lithotripsy procedure performed on (b)(6) 2023.During preparation, the device package was opened and found the coil of the stone cone was deformed and flat.The procedure was aborted and was postponed on an unknown date.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported that a stone cone was to be used on a flexible ureteroscopic lithotripsy procedure performed on (b)(6) 2023.During preparation, the device package was opened and found the coil of the stone cone was deformed and flat.The procedure was aborted and was postponed on an unknown date.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h2: initial reporter's second address is (b)(6).Block h6: imdrf impact codes f1001 capture the reportable event of absence of treatment.The returned stone cone was analyzed, and a visual inspection noted that the oil, sheath, working length, and handle revealed no defects.The functional test was conducted, demonstrating that the device could be opened and closed without any issues.The reported complaint has not been confirmed.Upon analyzing the device, no defects were found, and the device exhibited normal functionality with no observed deformations.Based on the analysis of the device's condition, the complaint is assigned an investigation conclusion code of 'no problem detected,' indicating that the reported device complaint or problem cannot be confirmed.

• Brand Name: STONE CONE
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16644878
• Report Number: 3005099803-2023-01553
• Device Sequence Number: 12301211
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0005934758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG